ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Be able to read, speak and understand English
- Have chronic moderate to severe pain for at least 3 months
- Require around the clock opioid medication for the relief of pain
- Have been taking a daily opioid for at least 30 days prior to starting the study
- Be able to be safely switched to a different pain medication
- Be practicing acceptable birth control methods for female patients of childbearing potential
- Be willing to participate in the study and able to comply with study procedures
- Be currently diagnosed with or participating in and/or seeking treatment for opioid
and/or alcohol abuse
- Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
- Be currently taking tramadol and/or extended release morphine products
- Have respiratory depression
- Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
- Have migraines as your main source of pain
- Have any form of bowel obstruction
- Be pregnant or breast feeding
- Have had 2 or more surgeries for low back pain
- Be planning a major surgery during the study
- Be staying in a hospital or nursing home
- Be planning to have steroid injections for your chronic pain during the study
- Have a life expectancy of less than 2 months
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Conversion to Embeda With Rescue Trial | |||
Official Title ICMJE | A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion | |||
Brief Summary | The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion. | |||
Detailed Description | The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first. | |||
Study Arms ICMJE | Experimental: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention: Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA) | |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 684 | |||
Original Estimated Enrollment ICMJE | 1300 | |||
Actual Study Completion Date ICMJE | April 2011 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 21 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01179191 | |||
Other Study ID Numbers ICMJE | ALO-01-10-4003 B4541001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |